Ampoule with protective sleeve for contamination prevention

ABSTRACT

An apparatus includes and ampoule and a protective sleeve. The ampoule includes a body portion and an openable end portion. The body portion defines an internal cavity for containment of a substance. The openable end portion is configured to be opened by removal of a distal section, which upon removal creates an opening into the internal cavity of the body portion for liberation of the substance from the internal cavity. The protective sleeve is disposed over at least a portion of the openable end portion. The protective sleeve provides a contamination barrier to prevent contamination of an outer surface of the openable end portion covered by the protective sleeve.

This application claims the benefit of U.S. Provisional Application No.61/394,719, filed on Oct. 19, 2010, entitled “Ampoule with ProtectiveSleeve for Contamination Prevention,” which is incorporated by referenceherein in its entirety.

The use of plastic ampoules for storing and dispensing fluid is widelyknown. Such ampoules serve as inexpensive and convenient methods fordispensing predetermined volumes of fluid. Generally, such ampoules arerelatively thin-wall, blow-molded containers which are formed via amolding process, filled with fluid then sealed closed in order tocompletely contain the fluid therein. There are many variables whichdefine the precise characteristics of the ampoule which may include thesize of the ampoule, the type of plastic and its relative thickness andopacity. Further, there are post process features or characteristicswhich can be imparted onto the ampoule such as markings relating to thetype of fluid inside, the volume of the contents, dates of manufactureor expiration, etc. One of the main reasons for the design and use ofplastic ampoules is their eventual disposability. They are usuallysingle use or single-patient use containers. In single use scenarios,the ampoule is opened, an amount of fluid is expelled, and the ampouleand any remaining fluid are discarded. In a single-patient use scenario,the ampoule may have more than a single dose of the fluid and can becapped off after partial use, with the constraint generally being thatthat ampoule be used only on the same patient. In either scenario, theampoule is used and partially or completely discarded appropriatelyafter use.

Generally speaking, ampoules have design characteristics that include aclosed end, a hollow central cavity, and a selectively openable sealedend. Such ampoules can be generally cylindrical in nature or more cubicin nature and, as mentioned, offer at least one end designed to beopened. In some cases, this openable end will have an area of engineeredweakness such as a discontinuous segment of wall thickness that isconducive to tearing at that location in order to open the ampoule at ornear that location of discontinuity. In this manner, the opening of theampoule is made feasible, particularly the opening of the ampoule byhand with a twisting motion or the like. The shape of the openable endis often identifiable owing to the shape of the discontinuity. In somecases, the shape is simply an elongate cross section of the main hollowcentral cavity. In other cases, the shape may be an elongate crosssection of the main hollow central cavity which tapered over somedistance in order to create a more conical shape. Additionally, theconical shape may be conducive to dispensing the contents of the ampouleinto precise locations owing to the funnel-like attributes that such aconical taper would afford.

In some cases, rather small amounts of fluid are desired to be placed inan ampoule. In order to mitigate the expense of raw materials and theimpact of disposal of used ampoules, the ampoule itself is sized inaccordance with the relative volume of the fluid intended to be placedtherein. In this case, there is a relationship between the eventual sizeof the ampoule and both the feasibility of manufacturing such an ampouleand the human factors relating to the ease of using such an ampoule. Itcan be appreciated that it is possible to create an ampoule that isgenerally too small to be handled, opened, or used easily and correctly.For this reason, ampoules are often designed with a vestige of materialadjacent to the removable end of the ampoule that enlarges the handlingsurface of the removable end in order to afford users more grip onto theampoule. A user grasps the body of the ampoule in one hand and graspsthis enlarged handling surface of the removable end in the other hand inorder to more easily impart the twisting motion required to open theampoule. However, with such a design there is an implied invitation tothe user, via the semantics of the device, to grasp anywhere on the bodyof the ampoule and anywhere on the removable end, generally, withoutregard to the precision of the placement of the grip, in order to openthe ampoule. In some settings and with some fluids such a random andhaphazard use scenario may be viewed as disadvantageous. One example ofthis is when the ampoule and its associated fluid are for use in medicalapplications where the fluid is clean and or sterile and the opening ofthe ampoule and dispensing of the fluid must not contaminate the fluid.Specifically, there are ampoules which are filled with water or salinefor rinsing or flushing associated with medical procedures where thewater or saline is placed in the ampoule at the time of manufacture, andwhen sealed the ampoule and its contents are rendered sterile by any ofseveral methods of terminal sterilization. In this case, the objectiveis for the fluid to be sterilized and to remain sterile up to andincluding the opening of the ampoule and the dispensing of the fluid.While a terminal sterilization process will yield an ampoule with asterile exterior surface and sterile contents, the exterior of theampoule will not remain sterile once removed from the sterilizationprocess. Any further handling of the ampoule relating to the eventualpackaging, storage and transportation of the ampoule can contaminate thepreviously sterilized portions of the ampoule. Despite the fact that theexterior of the ampoule may quickly become contaminated, the contents ofthe ampoule will remain sterile unless the integrity of the ampouleitself is somehow extraneously compromised, for example, resulting froma puncture or other similar intrusion. More precisely, the oftenhaphazard nature of removing the openable end of an ampoule, by the usergrasping and pinching on the ampoule, results in the generalcontamination of much of the surface adjacent to the openable end. Inthe case of sterile fluids, specifically those where the contents of theinterior of the ampoule are sterile and the exterior of the ampoule isnot sterile, there is a unpredictable and uncontrollable interfacebetween the sterile interior and the non-sterile exterior of the ampouleupon opening which makes it difficult to ensure that the act of openingthe ampoule doesn't permit or promote the contamination of the exteriorof the ampoule to migrate to and contaminate the interior of theampoule, the contents within the ampoule, or the contents flowing out ofthe ampoule. Specifically, once the ampoule is opened, the sterile fluidis expelled from the interior of the ampoule to the environment with thefluid passing at or near the unpredictable and uncontrollable interfacebetween the sterile interior and the non-sterile exterior. In thismanner, it is easy to appreciate the potential for contamination of thesterile fluid despite the best efforts of users not to touch,manipulate, or handle the surface immediately adjacent the openable endsimply because the sterile fluid passes at or near this interface.

Typical manufacturing processes used to create plastic ampoules do notafford many opportunities to inexpensively provide for touchcontamination prevention of the openable end of an ampoule. This islargely due to the “open and closed” molding process that does notreadily allow for the presence of undercuts in the geometry of themolded part which may prevent ready ejection of the molded part from themold tool on completion of the molding or plastic forming of the part.Thus, what are readily available in the market place are plasticampoules which are highly suited for virtually all aspects of their usebut are markedly lacking in their ability to promote their use in amanner which minimizes or prevents touch contamination and subsequentcontamination of the contents of the ampoule on discharge.

Embodiments described herein illustrate various aspects of a designhaving the utility of a disposable plastic ampoule that incorporatestouch contamination prevention measures. These, as well as other objectsand advantages of this invention, will be more completely understood andappreciated by careful study of the following more detailed descriptiontaken in conjunction with the accompanying drawings.

FIG. 1 is a front view of one embodiment of a disposable plastic ampoulewith a removable end.

FIG. 2 is a section view of one embodiment of a disposable plasticampoule with a removable end.

FIG. 3 is a side view of one embodiment of a disposable plastic ampoulewith a removable end in combination with a segment of an anti-touchcontamination sleeve.

FIG. 4 is a front view of one embodiment of a disposable plastic ampoulewith an anti-touch contamination sleeve in place at the removable end.

FIG. 5 is a section view of one embodiment of a disposable plasticampoule with an anti-touch contamination sleeve in place at theremovable end.

It will be readily understood that the components of the embodiments asgenerally described herein and illustrated in the appended figures couldbe arranged and designed in a wide variety of different configurations.Thus, the following more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thepresent disclosure, but is merely representative of various embodiments.While the various aspects of the embodiments are presented in drawings,the drawings are not necessarily drawn to scale unless specificallyindicated.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by this detailed description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

Reference throughout this specification to features, advantages, orsimilar language does not imply that all of the features and advantagesthat may be realized with the present invention should be or are in anysingle embodiment of the invention. Rather, language referring to thefeatures and advantages is understood to mean that a specific feature,advantage, or characteristic described in connection with an embodimentis included in at least one embodiment of the present invention. Thus,discussions of the features and advantages, and similar language,throughout this specification may, but do not necessarily, refer to thesame embodiment.

Furthermore, the described features, advantages, and characteristics ofthe invention may be combined in any suitable manner in one or moreembodiments. One skilled in the relevant art will recognize, in light ofthe description herein, that the invention can be practiced without oneor more of the specific features or advantages of a particularembodiment. In other instances, additional features and advantages maybe recognized in certain embodiments that may not be present in allembodiments of the invention.

Reference throughout this specification to “one embodiment,” “anembodiment,” or similar language means that a particular feature,structure, or characteristic described in connection with the indicatedembodiment is included in at least one embodiment of the presentinvention. Thus, the phrases “in one embodiment,” “in an embodiment,”and similar language throughout this specification may, but do notnecessarily, all refer to the same embodiment.

FIG. 1 illustrates one embodiment of a disposable plastic ampoule 10.The ampoule 10 has a closed end 20, an openable end 30, and a centralbody 40. Openable end 30 can be generally characterized as having anelongate section 31 with a proximal section 32 and a distal section 33and a narrowed section 34 there between. Further, in some embodimentsopenable end 30 is tapered with the proximal section 32 being the startof the taper and with the taper getting generally smaller as itprogresses toward distal section 33.

FIG. 2 is a cross section of ampoule 10 wherein narrowed section 34 ofopenable end 30 is seen to correspond to an interior section 50 having asingle interior cavity that is segmented into the fluid cavity 51 andthe tip cavity 52. In some embodiments, the distal section 33 is formedwithout an internal cavity.

FIG. 3 illustrates the application of one embodiment of an anti-touchcontamination sleeve 60 that is made from a heat sensitive material suchas heat shrink tubing used commonly to seal containers and the like. Inother embodiments, the sleeve 60 may be made from elastic or othermaterials that are at least temporarily deformable either inherently orthrough the application of some environmental condition. Sleeve 60 isillustrated as an elongate cylindrical tube with a sidewall 61 andopenings 62 and 63 on the ends. Alternatively, sleeve 60 may haveanother geometric configuration. For example, another embodiment ofsleeve 60 is open on a single end. In another embodiment, sleeve 60 maybe another shape other than cylindrical. Sleeve 60 is designed to fitcylindrically about openable end 30 of ampoule 10 such that portions ofproximal section 32 and all of distal section 33 and narrowed section 34of elongate section 31 can be covered by said sleeve. Alternatively, aportion of distal section 33 may be exposed and not covered by sleeve60. In some embodiments, at least the narrowed section 34 and a portionof the proximal section 32 are covered so that upon removal of thesleeve the covered portions will be free from contamination. Thisprovides a substantially sterile surface at the open end of the ampoule10 so that the fluid and/or patient are not contaminated by use of theampoule 10.

FIG. 4 shows sleeve 60 in place on the elongate section 31 of openableend 30 of ampoule 10 wherein heat has been applied to sleeve 60 in orderto cause it to constrict about openable end 30. The discontinuous natureof the elongate section 31 of openable end 30 allows the sleeve toconstrict in a manner in which it substantially conforms to the profileof openable end 30. End 62 of sleeve 60 is generally adjacent theproximal section 32 of openable end 30. End 63 is generally adjacent thedistal section (not visible in this view) of openable end 30. The lengthof sleeve 60 can be designed to be generally longer than elongatesection 31 of openable end 30 such that portions of sleeve 60 areunsupported beyond the surfaces of distal section. In thisconfiguration, unencumbered constriction of that portion of sleeve 60will result in the final diameter of sleeve 60, after heating, beingsmaller than the general outside diameter or size of the distal section.This, in combination with the constriction of sleeve 60 into narrowedsection 34 of elongate section 31 of openable end 30 causes sleeve 60 tobe effectively locked onto and non-removable from distal section 33 ofopenable end 30. End 62 of sleeve 60 then effectively becomes a coverover and around at least a portion of proximal section 32 of theopenable end 30 of ampoule 10. The size of sleeve 60 and the length ofthe ampoule 10 that is covered by the sleeve 60 determines the surfacearea of the ampoule 10 that remains free from contamination. In thismanner when a user grips ampoule 10 in order to open it, one hand can beused to grasp the body 40 and the opposing hand can be used to graspsubstantially the entirety of the elongate section 31 of openable end30. End 62 of sleeve 60 blocks the grasp of the hand directly ontosurfaces of openable end 30, thereby preventing touch contamination ofsaid surface.

Although the operations of the method(s) herein are shown and describedin a particular order, the order of the operations of each method may bealtered so that certain operations may be performed in an inverse orderor so that certain operations may be performed, at least in part,concurrently with other operations. In another embodiment, instructionsor sub-operations of distinct operations may be implemented in anintermittent and/or alternating manner.

Although specific embodiments of the invention have been described andillustrated, the invention is not to be limited to the specific forms orarrangements of parts so described and illustrated. The scope of theinvention is to be defined by the claims appended hereto and theirequivalents.

1. An apparatus comprising: an ampoule comprising: a body portion whichdefines an internal cavity for containment of a substance; and anopenable end portion coupled to the body portion, wherein the openableend portion is configured to be opened by removal of a distal section,which upon removal creates an opening into the internal cavity of thebody portion for liberation of the substance from the internal cavity;and a protective sleeve disposed over at least a portion of the openableend portion, wherein the protective sleeve provides a contaminationbarrier to prevent contamination of an outer surface of the openable endportion covered by the protective sleeve.
 2. The apparatus of claim 1,wherein the openable end portion of the ampoule is tapered so that theopenable end portion is generally narrower near the distal section thanat a proximal section adjacent to the body portion of the ampoule. 3.The apparatus of claim 2, wherein the protective sleeve is tapered tosubstantially fit the taper of the openable end portion of the ampoule.4. The apparatus of claim 3, wherein removal of the distal section ofthe openable end portion of the ampoule additionally removes theprotective sleeve from the proximal section of the openable end portionof the ampoule.
 5. The apparatus of claim 1, wherein the protectivesleeve comprises a closed end to fully encapsulate the openable endportion of the ampoule.
 6. The apparatus of claim 1, wherein theprotective sleeve comprises a deformable material configured to deformto substantially fit a surface feature of the openable end portioncovered by the protective sleeve.
 7. The apparatus of claim 6, whereinthe protective sleeve comprises a heat shrink material.
 8. A method ofusing an ampoule comprising: grasping the ampoule at approximately abody portion of the ampoule; grasping an openable end portion of theampoule at approximately a distal section, the openable end portion atleast partially covered by a protective sleeve to prevent contaminationof an outer surface of the openable end portion of the ampoule; breakinga weakness in the openable end portion of the ampoule to separate thedistal section from the ampoule; and removing the distal section of theampoule, wherein removal of the distal section of the ampoule removessubstantially all of the protective sleeve from the ampoule.
 9. Themethod of claim 8, wherein the openable end portion of the ampoule has asurface feature to facilitate retention of the protective sleeve untilremoval of the distal section of the ampoule.
 10. The device of claim 9,wherein the surface feature comprises a raised collar.
 11. The device ofclaim 8, wherein the openable end portion of the ampoule is tapered sothat the openable end portion is generally narrower near the distalsection than at a proximal section adjacent to the body portion of theampoule.
 12. The device of claim 11, wherein the protective sleeve istapered to substantially fit the taper of the openable end portion ofthe ampoule.
 13. The device of claim 8, wherein breaking the weakness inthe openable end of the ampoule comprises twisting the distal section ofthe ampoule.
 14. The device of claim 8, wherein the protective sleevecomprises a closed end to fully encapsulate the openable end portion ofthe ampoule.
 15. The device of claim 9, wherein the protective sleevecomprises a deformable material that is configured to deform tosubstantially fit the surface feature of the outer surface of theopenable end portion covered by the protective sleeve.
 16. The device ofclaim 15, wherein the protective sleeve comprises a heat shrinkmaterial.
 17. A method comprising: forming an ampoule, the ampoulecomprising: a body portion which defines an internal cavity forcontainment of a substance; and an openable end portion coupled to thebody portion, wherein the openable end portion is configured to beopened to create an opening into the internal cavity of the body portionfor liberation of the substance from the internal cavity; and disposinga protective sleeve over at least a portion of the openable end portion,wherein the protective sleeve provides a contamination barrier toprevent contamination of an outer surface of the openable end portioncovered by the protective sleeve.
 18. The method of claim 17, whereindisposing the protective sleeve over at least the portion of theopenable end portion comprises sliding the protective sleeve over theopenable end portion from a distal end relative to the body portion, theprotective sleeve comprising a deformable material.
 19. The method ofclaim 18, wherein disposing the protective sleeve over at least theportion of the openable end portion further comprises treating theprotective sleeve to prevent contamination of the outer surface of theopenable end portion of the ampoule.
 20. The method of claim 19, whereintreating the protective sleeve comprises applying heat to the protectivesleeve to shrink the protective sleeve.